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A Study of Adjuvant Cretostimogene Grenadenorepvec for Treatment of Intermediate Risk NMIBC Following TURBT

NCT06111235 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 367

Last updated 2026-01-12

No results posted yet for this study

Summary

This is a Phase 3, open-label, randomized trial designed to evaluate the RFS of TURBT followed by cretostimogene grenadenorepvec versus TURBT followed by surveillance for the treatment of participants with IR-NMIBC.

Conditions

Interventions

DRUG

Cretostimogene Grenadenorepvec

Engineered Oncolytic Adenovirus

OTHER

n-dodecyl-B-D-maltoside

Transduction-enhancing agent

Sponsors & Collaborators

  • CG Oncology, Inc.

    lead INDUSTRY

Principal Investigators

  • Max Kates, MD · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-14
Primary Completion
2026-06-30
Completion
2029-02-28
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06111235 on ClinicalTrials.gov